Journal
DRUG INFORMATION JOURNAL
Volume 34, Issue 2, Pages 355-363Publisher
DRUG INFORMATION ASSOCIATION
DOI: 10.1177/009286150003400204
Keywords
clinical trials; sample size determination; fully Bayesian approach; expected net benefit; regulatory authority
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In this paper we introduce a fully Bayesian approach to sample size determination in clinical trials. In contrast to the usual Bayesian decision theoretic methodology, which assumes a single decision maker our approach recognizes the existence of three decision makers, namely: the pharmaceutical company conducting the trial, which decides on its size; the regulator whose approval is necessary for the drug to be licensed for sale; and the public at large, who determine ultimate usage. Moreover we model the subsequent usage by plausible assumptions for actual behavior rather than assuming that it represents decisions which are in some sense optimal. The results, not surprisingly, show that the optimal sample size depends strongly on the expected benefit from a conclusively favorable outcome, and on the strength of the evidence required by the regulator.
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